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CompletedNCT01368952Updated Jun 8, 2011

The Effect of Pure Prone Positioning Therapy for the Patients With Mild to Moderate Obstructive Sleep Apnea

An interventional study of Pure prone positioning in Obstructive Sleep Apnea, sponsored by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-06-08.

Sponsored by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Efficacy of Pure Prone Positioning (PPP) treatment in improving apnea-hypopnea index (AHI) and nocturnal oxygen saturation was investigated in mild to moderate Obstructive Sleep Apnea.

Read the detailed description

Sleeping in prone position could be effective in the management of obstructive sleep apnea (OSA) by reducing the gravity effect on the upper airway and hence collapsibility. Pure prone positioning (PPP) consisted of a pillow mounted on a table designed to keep the subjects sleeping prone with the head extended in line with the body.

02

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • Obstructive Sleep Apnea
  • Prone positioning
  • Positional Treatment
  • Hypoxemia
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 29 is below the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients were enrolled to the study among one hundred and eighty-four consecutive patients who were admitted to our sleep center with 6 beds in a tertiary care hospital, during 3 months period. Of these, 36 patients with mild to moderate OSA (AHI=5-30 events/h) were invited to participate in the study based on the selection criteria, and 29 patients with mild to moderate OSA on their baseline PSG, (17 males, 12 females) gave informed consent and participated in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients having BMI>35 and/or abdominal and/or trunkal obesity that may hinder prone sleeping , upper airway pathology (nasal polyp, nasal turbinate hypertrophy, chronic sinusitis, nasal septum deviation, upper airway infection, Mallampati score and tonsil size grade of IV), any other concomitant sleep disorder (narcolepsy, periodic leg movement syndrome, insomnia, sleep related hypoventilation-hypoxemia and central sleep apnea syndrome), psychiatric disorder such as panic disorder, heart failure and coronary artery disease were not included in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
29 participants (actual)

Study arms

  • Active comparator
    Pure Prone Positioning

    Sleeping in prone position by pure prone positioning device, which consisted of a pillow mounted on a table designed to keep the subjects sleeping prone.

    Device: Pure prone positioning

  • No intervention
    Baseline

    No intervention for sleep position

Interventions

  • DevicePure prone positioning

    Pure prone positioning device consisted of a pillow mounted on a table designed to keep the subjects sleeping prone.

    Also known as: Positional treatment

06

What researchers measure

Primary outcomes

  1. Apnea-hypopnea index (AHI)

    Reduction in AHI during pure positioning night as compared to baseline night

    Time frame: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''

Secondary outcomes

  1. Nocturnal oxygen saturation

    Comparison of mean oxygen saturation, minimum oxygen saturation and proportion of time spent during sleep with oxygen saturation below 90% (as measures of nocturnal hypoxemia) in pure prone positioning night with that of the baseline night.

    Time frame: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''

  2. Sleep efficiency

    Improvement in sleep efficiency in prone positioning night as compared to baseline night.

    Time frame: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''

07

Study locations

1 site
  • The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital
    Izmir, 35110, Turkey
08

References and documents

Publications

  • George CF, Millar TW, Kryger MH. Sleep apnea and body position during sleep. Sleep. 1988 Feb;11(1):90-9. doi: 10.1093/sleep/11.1.90. PubMed 3363274 ↗
  • Matsuzawa Y, Hayashi S, Yamaguchi S, Yoshikawa S, Okada K, Fujimoto K, Sekiguchi M. Effect of prone position on apnea severity in obstructive sleep apnea. Intern Med. 1995 Dec;34(12):1190-3. doi: 10.2169/internalmedicine.34.1190. PubMed 8929648 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01368952
Lead sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
First posted
Jun 8, 2011
Start date
Mar 2011
Primary completion
May 2011
Completion
May 2011
Last update
Jun 8, 2011

Study contacts

Arman Afrashi, MD
principal investigator · The Department of Otolaryngology-Head and Neck Surgery, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, Izmir, Turkey
Zeynep Z Ucar, MD
study director · The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, Izmir, Turkey

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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